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Terminated

BIOMET 3i LOCATOR ABUTMENT, Catalog/Item Number: LOA002, 2.0mm, BioMet 3i, Palm Beach, FL.

FDA Recall Z-1363-2008 · Posted None

Recalling FirmBiomet 3i, Inc.
Recall StatusTerminated
Product CodeDZE
Date Initiated2008-02-07
Date Terminated2008-07-10
Product Quantity100

Reason for Recall

Mispackaging: The Locator Abutment labeled as LOA002 may contain Catalog/Item # LOA003 product and visa versa

Firm Action

Each USA customer was contacted by telephone and then by letter, Urgent Medical Device Recall, dated 2/15/2008, sent by fax. International customers were first contacted by E-mail then by fax letter also. Each customer was instructed to check their respective inventory for the affected part and corresponding lot number. They were then requested to fax back a response form to Biomet 3i Regulatory Services to provide feedback concerning their inventory for product return. They were also instructed to return the affected product to Biomet 3i.

Root Cause

Other

Distribution Pattern

Worldwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K0129113I LOCATER ABUTMENT SYSTEMImplant Innovations, Inc. · 2001-09-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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